The European Commission (EC) has approved Arixtra (fondaparinux sodium) of GlaxoSmithKline for prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.
“Because many patients undergoing abdominal surgery are judged to be at high risk of developing VTE, this new indication for Arixtra represents an important and exciting medical development for patients,” Andrew Witty, president of GlaxoSmithKline Pharmaceuticals Europe said adding, “Patients in the EU who are judged to be at high risk of thromboembolic complications during abdominal surgery, especially those with cancer, can now benefit from VTE protection with once-a-day Arixtra.”
The EC’s decision was based on the results of the PEntasaccharide GenerAl SUrgery Study (PEGASUS). This study demonstrated that Arixtra is at least as effective as dalteparin in reducing the risk of total VTE. PEGASUS was a double-blind study performed in 131 centres in 22 countries.
Arixtra is an anti-thrombotic agent already approved for use in the European Union (EU) for the prophylaxis of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery for hip fracture, knee replacement, and hip replacement, and acutely ill medical patients.